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NCT Number: NCT07483268

A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

CRSwNP

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged 18 years or older at the time of informed consent and provide voluntary informed consent to participate in the study before inclusion in the study.
  • Physician decision to treat the participant with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.

Exclusion criteria

  • Known history of allergic reaction to Stapokibart Injection.
  • Participants currently or plan participating in any interventional clinical trial.
  • Participants with hematologic malignancies.
  • Women with pregnant.
  • Any condition that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.

Treatment and study plan

Stapokibart

Biological

subcutaneous injection

Primary outcomes

  1. The incidence rate of adverse reactions (ADR).

    Time frame: From enrollment to the end of treatment at 52 weeks

    Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA)

Sponsors and collaborators

Lead sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Industry

Registry information

Official study title

A Prospective Study of Stapokibart Injection in Patients With CRSwNP

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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